Padua Prediction Score for VTE Risk in Thoracic Surgery Patients

NCT06732726 | Not Yet Recruiting DMC

• 2 other identifiers: UNCOMIRB20241210008
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to assess the predictive accuracy of the Padua Prediction Score (PPS) for venous thromboembolism (VTE) risk in thoracic surgery patients. The study aims to answer the following question: Does the PPS provide a more accurate prediction of VTE risk? Participants will: Have their VTE risk assessed using the PPS during their hospital admission.

Conditions

DVT - Deep Vein Thrombosis; VTE (Venous Thromboembolism)

Keywords

Padua Prediction Score (PPS)

Outcome Measures

Primary Outcomes (2)

• Incidence of Venous Thromboembolism (VTE) Episodes in Patients

  symptomatic or asymptomatic, confirmed by instrumental diagnostics.

  In-Hospital Phase (average of 10 days through discharge); Post-Discharge Follow-Up: Day 7, Day 15, and Day 30

• Padua Prediction Score

  A total score that ranges from 0 to 20. 4 or higher indicates a significant likelihood of developing VTE.

  Day 1 preoperative (one day prior to surgery)

Secondary Outcomes (2)

• Incidence of Symptomatic Pulmonary Embolism in Patients

  In-Hospital Phase (average of 10 days through discharge); Post-Discharge Follow-Up: Day 7, Day 15, and Day 30

• Rate of Recurrent Deep Vein Thrombosis (DVT) in Patients

  Post-Discharge Follow-Up: Day 7, Day 15, and Day 30

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will focus on adult patients undergoing thoracic surgery at a single center in Iraq.

You may qualify if:

• Patients who have undergone preoperative Padua Prediction Score assessment.
• Inpatients with a hospital stay over 3 days
• Written informed consent obtained from patients or their legal guardians.
• Availability for postoperative follow-up to assess outcomes like LEVT development or related complications.

You may not qualify if:

• Preexisting LEVT or pulmonary embolism.
• Severe Coagulopathy: Patients with inherited or acquired bleeding disorders (e.g., hemophilia, advanced liver disease).
• receiving any anticoagulation therapy for any reason.
• patients who did not undergo a postoperative D-dimer test.
• Incomplete Data: missing essential clinical or laboratory data.
• Pregnancy: pregnant women or those within six weeks postpartum.
• Noncompliance: Patients unwilling or unable to adhere to study follow-up protocols.

Sponsors & Collaborators

• Al-Nahrain University: lead

Study Sites (1)

College of Medicine - Al-Nahrain University

Baghdad, Kadhimiya, Iraq

Location

Related Publications (2)

• Al Yami MS, Silva MA, Donovan JL, Kanaan AO. Venous thromboembolism prophylaxis in medically ill patients: a mixed treatment comparison meta-analysis. J Thromb Thrombolysis. 2018 Jan;45(1):36-47. doi: 10.1007/s11239-017-1562-5.

  PMID: 29043538 BACKGROUND

• Barbar S, Noventa F, Rossetto V, Ferrari A, Brandolin B, Perlati M, De Bon E, Tormene D, Pagnan A, Prandoni P. A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score. J Thromb Haemost. 2010 Nov;8(11):2450-7. doi: 10.1111/j.1538-7836.2010.04044.x.

  PMID: 20738765 RESULT

MeSH Terms

Conditions

Venous Thrombosis; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism

Study Officials

• Yaser aamer Eisa Alhaibi, Assistant professor

  College Of Medicine - Nahrain University

  STUDY DIRECTOR

Central Study Contacts

Abdul-Ilah R. Khamis

CONTACT

+9647838571013; allaabed987@ced.nahrainuniv.edu.iq

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: April 20, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 15, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)